United States Food and Drug Administration (USFDA) has concluded pre-approval inspection (PAI) at Jubilant Pharmova’s stepdown subsidiary -- Jubilant Generics' solid dosage formulations facility at Roorkee site, India. The USFDA has issued 4 observations pursuant to the completion of audit. The company will submit an action plan on the observations.
The site’s revenue from the US market in the trailing twelve-month period (July 2024 to June 2025) is less than one percent of Jubilant Pharmova revenues in the same period.
Jubilant Pharmova (formerly Jubilant Life Sciences) is a company engaged in pharmaceuticals, contract research and development services and proprietary novel drugs businesses.
